US2019134382A1PendingUtilityA1

Method and system for adjusting stimulation therapy

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Assignee: PACESETTER INCPriority: Nov 8, 2017Filed: Nov 8, 2017Published: May 9, 2019
Est. expiryNov 8, 2037(~11.3 yrs left)· nominal 20-yr term from priority
A61N 1/0551A61N 1/36132A61N 1/36071A61N 1/36062A61B 5/04001A61N 1/36135A61N 1/37247A61N 1/36017A61B 5/24
38
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Claims

Abstract

The systems and methods described herein generally relate to spinal cord stimulation (SCS) therapy and more particularly to monitoring the SCS therapy and determining an adjustment to a position of a lead or electrodes delivering the SCS therapy to the patient. The systems and methods deliver a SCS therapy to a portion of an array of electrodes of a lead, and analyze physiological signals measured by a set of sensors relative to each other. The set of sensors are positioned bilaterally on a patient. Further, the systems and methods determine an adjustment in a position of the lead or the SCS therapy based on a relation between the physiological signals.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A clinician programmer device for controlling a neurostimulation system including a pulse generator and a stimulation lead during an implant procedure, comprising:
 a controller for controlling the device according to executable instructions;   a display for providing a user interface to a user of the device;   memory for storing executable instructions and data; and   circuitry for communicating with a plurality of sensors for sensing physiological signals from a patient when the plurality of sensors are positioned bilaterally on the patient;   wherein the controller is configured to execute instructions stored in the memory to: (1) communicate with the pulse generator to apply spinal cord stimulation to the patient through the stimulation lead, (2) communicate with the plurality of sensors to acquire physiological data from the patient occurring in response to the spinal cord stimulation, (3) process the acquired physiological data to identify non-symmetry of the patient's physiological response detected using at least one set of bilaterally positioned sensors of the plurality of sensors, (4) identify a potential spatial adjustment of the stimulation lead to reduce or eliminate the non-symmetry of the patient's physiological response, and (5) display an indication of the spatial adjustment on the display to the user of the device.   
     
     
         2 . The device of  claim 1 , wherein the controller is configured to execute instructions to identify differences in amplitude in physiological data from respective sensors of the at least one set of bilaterally positioned sensors. 
     
     
         3 . The device of  claim 1 , wherein the controller is configured to execute instructions to identify differences in phase in physiological data from respective sensors of the at least one set of bilaterally positioned sensors. 
     
     
         4 . The device of  claim 1 , wherein the controller is configured to identify differences in onset time of the patient's physiological response in physiological data from respective sensors of the at least one set of bilaterally positioned sensors. 
     
     
         5 . The system of  claim 1  wherein the controller circuit is configured to display a user interface component depicting the patient's physiological response and the user interface component includes an indication of respective sets of physiological data, detected using the at least one set of bilaterally positioned sensors, relative to each other. 
     
     
         6 . The system of  claim 5 , wherein the user interface component is a gauge, a bar graph, a graph, an arrow, textual information, a graphical icon, a heat map, a pie chart. 
     
     
         7 . The system of  claim 1 , wherein the controller circuit is configured to execute a configuration phase of operation to apply spinal cord stimulation for normalization of physiological signals before identification of spatial adjustment of the stimulation lead is performed. 
     
     
         8 . The system of  claim 1 , wherein the plurality of sensors are adapted for positioning at an opposing bilateral muscle group of the patient, wherein the opposing bilateral muscle group includes a gluteus maxims, tensor fasciae latae, quadriceps, or soleus muscle. 
     
     
         9 . The system of  claim 1 , wherein the patient's physiological response is determined by measuring electromyography activity. 
     
     
         10 . The system of  claim 1  wherein the controller is configured to detect whether the stimulation lead is positioned in a canted orientation within an epidural space of the patient and to identify a spatial adjustment on the display to move the stimulation lead to reduce or eliminate the canted orientation. 
     
     
         11 . A clinician programmer device for controlling a neurostimulation system including a pulse generator and a stimulation lead during an implant procedure, comprising:
 a controller for controlling the device according to executable instructions;   a display for providing a user interface to a user of the device;   memory for storing executable instructions and data:   wireless communication circuitry connected to the controller, wherein the controller is configured to wirelessly communicate with a plurality of sensors using the wireless communication circuitry to obtain physiological data when the plurality of sensors are positioned bilaterally on the patient; and   wherein the controller is configured to execute instructions stored hi the memory to: (1) communicate with the pulse generator to apply spinal cord stimulation to the patient through the stimulation lead, (2) communicate with the plurality of sensors to acquire physiological data from the patient occurring in response to the spinal cord stimulation, (3) process acquired the physiological data to identify non-symmetry of the patient's physiological response detected using at least one set of bilaterally positioned sensors of the plurality of sensors, (4) identify a potential spatial adjustment of the stimulation lead to reduce or eliminate the non-symmetry of the patient's physiological response, and (5) display an indication of the spatial adjustment on the display to the user of the device.   
     
     
         12 . The device of  claim 11 , wherein the controller is configured to execute instructions to identify differences in amplitude in physiological data from respective sensors of the at least one set of bilaterally positioned sensors. 
     
     
         13 . The device of  claim 11 , wherein the controller is configured to execute instructions to identify differences in phase in physiological data from respective sensors of the at least one set of bilaterally positioned sensors. 
     
     
         14 . The device of  claim 11 , wherein the controller is configured to identify differences in onset time of the patient's physiological response in physiological data from respective sensors of the at least one set of bilaterally positioned sensors. 
     
     
         15 . The system of  claim 11 , wherein the controller circuit is configured to display a user interface component depicting the patient's physiological/response and the user interface component includes an indication of respective sets of physiological data, detected using the at least one set of bilaterally positioned sensors, relative to each other. 
     
     
         16 . The system of  claim 15 , wherein the user interface component is a gauge, a bar graph, a graph, an arrow, textual information, a graphical icon, a heat map, a pie chart. 
     
     
         17 . The system of  claim 15 , wherein the controller circuit is configured to execute a configuration phase of operation to apply spinal cord stimulation for normalization of physiological signals before identification of spatial adjustment of the stimulation lead is performed. 
     
     
         18 . The system of  claim 11 , wherein the plurality of sensors are adapted for positioning at an opposing bilateral muscle group of the patient, wherein the opposing bilateral muscle group includes a gluteus maximus, tensor fasciae latae, quadriceps, or soleus muscle. 
     
     
         19 . The system of  claim 11 , wherein the patient's physiological response is determined by measuring electromyography activity. 
     
     
         20 . The system of  claim 11 , wherein the controller is configured to detect whether the stimulation lead is positioned in a canted orientation within an epidural space of the patient and to identify a spatial adjustment on the display to move the stimulation lead to reduce or eliminate the canted orientation.

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